Dr. Sitaramesh Emani, MD, Cardiologist at The Ohio State Wexner Medical Center, talks about an experimental device designed to treat patients with heart failure that is getting worse.
Interview conducted by Ivanhoe Broadcast News in April 2022.
TELL US WHAT’S HAPPENING WHEN YOU SAY SOMEBODY HAS HEART FAILURE OR ADVANCED HEART FAILURE?
DR EMANI: Heart failure is a term that we use broadly but describes a situation where the heart is inefficient in its pumping mechanism, and because of that, not enough blood flow is getting forward to the rest of the body. Patients will often feel tired, fatigued, out of energy because of that lack of forward flow, but also that causes a backup of fluid into the lungs, into the stomach, causes patients to feel extremely short of breath. Their stomach can feel bloated or full or their legs, ankles, feet can become very swollen.
THIS IS SOMETHING THAT DEVELOPS OVER A PERIOD OF TIME FOR MOST PATIENTS, OR CAN IT COME ON SUDDENLY?
DR EMANI: Both. There’s a sudden onset heart failure that can come from an injury to the heart or something that’s happened more suddenly, or the vast majority of the patients that we tend to see in the hospital, something has happened over a slow but maybe undetected period of time, days to weeks, until the symptoms become bad enough that they have to come into the hospital for additional treatments.
IS THIS SOMETHING THAT’S FAIRLY COMMON?
DR EMANI: It is, it’s very common. In fact, it’s one of the leading causes of hospitalization in the United States.
WHAT ARE FIRST LINE TREATMENTS?
DR EMANI: First line treatment is to make people breathe better. The vast majority will come in again feeling short of breath because of this backup of fluid. We utilize what are commonly called water pills or intravenous versions of a water pill to help remove the excess fluid within the body.
YOU HAD MENTIONED SOME OTHER SYMPTOMS, BLOATING, FEELING FULL, BUT ARE THERE ANY OTHER CARDIOVASCULAR SYMPTOMS? FOR EXAMPLE, WILL A PATIENT FEEL THEIR HEART RACE, OR WILL THEY CHECK THEIR BLOOD PRESSURE OR PULSE AND SEE, WOW, THAT’S OUT OF WHACK?
DR EMANI: Any number of disturbances, elevated heart rate, the sensation of elevated heart rate or skipped beats, palpitations. Patients may also sometimes feel a little bit of chest heaviness or pressure because of that backup and the shortness of breath that goes along with it. Oftentimes, loved ones or those close to the patient will say that they look a little gray or lack color, and when they go to touch, they’ll feel cool to touch.
WHAT’S HAPPENING THAT PATIENTS LOOK GRAY AND THEY FEEL COLD?
DR EMANI: Again, if there’s not enough blood flow moving to the rest of the body, the body sort of doesn’t get the normal oxygen to its tissues and that makes people look gray or sick.
IF YOU CAN TALK TO ME A LITTLE BIT ABOUT THE NEUROMODULATION DEVICE. WHAT IS IT AND WHAT’S IT DESIGNED TO DO?
DR EMANI: The specific device here is targeting the nerves that help modulate or control how the heart works. Our aim is to improve the efficiency, so not just the side effects or the downstream problems related to the fluid buildup, but actually make the heart pump better so we can improve the efficiency, improve the forward flow, and then relieve the congestion that comes with acute heart failure. The nerves that we are targeting here sit in the chest next to the lungs and then attach to the heart. We call those the cardiopulmonary nerves.
CAN YOU WALK ME THROUGH THE DEVICE ITSELF AND THEN I’M GOING TO ASK YOU HOW IT’S IMPLANTED AND HOW IT WORKS?
DR EMANI: The device is actually a series of electrodes that deliver electrical stimulus directly to the nerves, and we place it within the body into a strategic and specific location where these nerves are located so that we can stimulate the nerves, specifically driving the heart’s efficiency to make it squeeze better. This device sits in the body for a temporary period of time, a couple of days, delivering therapy to improve the efficiency, make patients feel better, hopefully get them out of the hospital sooner in a better state than they were when they came in.
DESCRIBE FOR ME HOW IT’S IMPLANTED AND THEN HOW IT WORKS?
DR EMANI: The nerves sit alongside a main artery called the pulmonary artery. In order to get to the pulmonary artery, we can go through any vein. In this particular case, we go through the internal jugular vein in the neck. Under our special X-ray equipment in our Cath-lab, we make an incision into the vein, put a special tube. Through that tube we place a wire that we can then direct into the pulmonary artery, which is directly on top of and just slightly behind the heart. Over the wire, we deliver these electrodes that are on a basket. That basket then sits in the artery with an external wire component that we hook up to the controller that delivers the electrical stimulus and allows us to monitor the patient and the patient’s response.
HOW BIG IS THAT BASKET?
DR EMANI: The basket expands, and we have sized it appropriately to the patient. When we first put it in, it comes in a very thin wrapped up state that looks a lot like a pencil might. When we expand it, it opens up to about 22 millimeters to 38 millimeters in diameter.
IS IT CORRECT TO CALL THIS MINIMALLY INVASIVE? YOU’RE NOT CUTTING OR MAKING MAJOR INCISIONS ANYMORE, ARE YOU?
DR EMANI: Correct. This would be considered a minimally invasive procedure.
WE HAD SEEN SOME PICTURES FROM ROBERT WHERE HE HAD A DEVICE AT HIS NECK. CAN YOU EXPLAIN WHAT THAT IS?
DR EMANI: Once we position that basket into the correct place in order to deliver the electrical stimulus and then monitor the patient both internally and externally, some portion of that has to connect to our controllers outside, and so that portion comes out through the tube that we placed in the vein in the neck. We tape that up to remain sterile, but then that portion extends out to a controller unit on the side while it’s in place, and the patient does have something attached to them. When we’re done, all of that comes out.
IS IT POWERED BY ELECTRICITY? DOES THE CONSOLE PLUG IN?
DR EMANI: The console is plugged in. These are actual electrical signals going into the body.
CAN THE PATIENT FEEL IT?
DR EMANI: Our patients have told us they can tell when we turn on the therapy. We try very hard and our attempt here is to make sure it doesn’t cause discomfort, but in fact, what they’re feeling is improvement in their heart function.
NOW HAVE YOU DONE THIS MORE THAN ONCE? I KNOW ROBERT WAS YOUR FIRST.
DR EMANI: Correct. We have.
WHAT ARE YOU FINDING IN TERMS OF SUCCESS RATES? HOW ARE PATIENTS FEELING AFTER THIS IS DONE?
DR EMANI: So far, we’ve had very good success. Our patients are reporting that they feel better. We use certain medical measurements to see if we are appropriately treating and showing improvement, and we are seeing those improvements as well. We think the heart is beating stronger, is beating better when this therapy is turned on, and then interestingly and importantly, we’re seeing that improvement last even after we take the treatment out.
HOW LONG IS THAT EFFECT DESIGNED TO LAST? COULD IT BE JUST THAT YOU NEED THE ONE TUNEUP AT THE HOSPITAL AND YOU’RE GOOD TO GO?
DR EMANI: That’s what we hope. We hope that this will help get patients over the hump, so to speak, and then on to better treatments to treat their heart failure in the long term, but that this would avoid a future need for a hospitalization.
IS THERE ANY THERAPY THAT’S DONE IN CONJUNCTION WITH THAT? FOR EXAMPLE, IS ROBERT STILL ON OR ARE ANY PATIENTS STILL ON MEDICATION? HOW MUCH FOLLOW UP IS THERE?
DR EMANI: As with all of our trial devices and trial therapies, we do this in conjunction with all of the standard proven therapies. So Robert, for example, received the IV water pills while he had this treatment and we continue to use the medicines that have already been shown to help the heart. The treatment that we deliver is intended to augment what we already do.
WHICH PATIENTS WOULD BENEFIT THE MOST FROM THIS?
DR EMANI: When patients come in, they come in, as you can imagine, in a variety of ways and different levels of sickness. We’re targeting the patients that are a little bit sicker than the average heart failure patient. These are patients for whom the total amount of blood flow, when measured directly from their heart to the rest of our body, is considered quite low and we would consider for treatments that have been reserved for the sickest of patients in the past, special IV medicines that are again meant to improve the amount of blood flow. Those other more traditional medications, though, come with a little bit of cost. They can add strain or stress to the heart, and they have never been proven to show outcomes better over the long period. So, we’re hoping to find a way to treat these sicker patients, patients for whom their cardiac output is extremely low, in a way that will actually benefit them more than our currently available treatments, IV treatments.
WHEN PATIENTS GET TO THIS POINT, DOCTOR, ARE THEY KIND OF ON THE ROAD TO TRANSPLANT? ARE YOU GETTING TO THE POINT WHERE THERE REALLY IS NOT MUCH ELSE THAT WILL HELP?
DR EMANI: We hope not. We hope that this is a good stopgap in order to treat them and avoid the most extreme of treatments we have available.
WITHOUT THE NEURO IS THERE ANYTHING ELSE? IF THE MORE INTENSIVE DRUGS DON’T WORK, DO THEY HAVE ANY OTHER OPTIONS?
DR EMANI: For some patients, but unfortunately not every patient, mechanical heart pumps and transplant are an option.
I WANT TO TALK A LITTLE BIT ABOUT YOUR FIRST PATIENT ROBERT. CAN YOU TELL ME A LITTLE BIT ABOUT HIM AND HIS CASE?
DR EMANI: Robert came to the office that day not feeling well. In fact, when we talked to him some more, he told us over the couple of weeks prior to presenting, he just was out of energy. He was feeling tired. He wasn’t the same. His family agreed that he wasn’t the same guy that he usually was. He was worried that he was reaching the end of the road. He was diagnosed with a potential heart problem. We saw him in our office and realized he needed to be hospitalized to receive more treatment because his heart failure had become fairly significant at that point. When he came into the hospital, we realized his cardiac output was low. We approached him about this treatment saying, we think that this is going to make you feel better and make you feel better faster than our normal treatments might.
WHAT ABOUT ROBERT MADE HIM AN IDEAL CANDIDATE IN YOUR MIND?
DR EMANI: He met all the medical criteria to start. He had that inefficiency of the heart. He had the backup of fluid into his lungs. He wasn’t getting enough blood flow to his other organs. So, that was definitely the first thing we looked at to say he would be a good candidate. Moreover, he was willing to undergo a procedure that’s considered experimental and, you know, we thought we could do and were able to put the device in safely.
ROBERT AND HIS WIFE MENTIONED THAT HE WAS ICE COLD. SHE SAID HIS HANDS WERE CLAMMY. HIS BODY WAS JUST COLD TO THE TOUCH. WHAT WAS CAUSING THAT?
DR EMANI: There was not enough blood flow to the fingertips, the toes, the places furthest away from the heart, there just wasn’t enough strength in the heart to push blood all the way out to those extremities.
I THINK ONE OF THE THINGS THAT HIS WIFE SAID IS THAT A MEDICAL PROFESSIONAL HAD LOOKED AT HIM AND SAID HE’S MORE DEAD THAN ALIVE RIGHT NOW AND THEY BOTH JOKE ABOUT IT, BUT THAT KIND OF DROVE IT HOME. I WANTED TO ASK YOU, WAS ROBERT AT THE POINT WHERE HE WAS REALLY IN A LOT OF DANGER?
DR EMANI: He was in danger. He was very sick and in patients that don’t have enough blood flow, they’re at risk of organs shutting down. They’re really advancing the need of certain types of life support. So, he was a very sick gentleman when he came into the hospital.
HOW’S HE DOING NOW?
DR EMANI: He’s doing great right now. When he left the hospital, he felt a lot better, his blood pressures were better, importantly, when you touched his hands, they were warm. He was walking, not short of breath. The energy was starting to come back. Afterwards, when we’ve seen him in the office, I think he’s back to doing all of the great activities that he loves to do.
HE TOOK THE BASKET HOME AS A SOUVENIR.
DR EMANI: Yes.
HE WAS THE FIRST IN THE COUNTRY DONE? I JUST WANTED TO CONFIRM THAT.
DR EMANI: He was the first in the country to receive this therapy.
IS THERE ANYTHING I DIDN’T ASK YOU, DOCTOR, THAT YOU WOULD WANT TO MAKE SURE THAT PEOPLE KNOW ABOUT THIS PROCEDURE?
DR EMANI: The procedure is, again, reserved for patients who are relatively sick. It’s a procedure that as of right now, we only deliver in the hospital with the hopes that we can make patients better in the long term. We, again, always want to be sure we’re doing all the things that are already proven. So, every patient receives treatments that are shown to work, and for those for whom the standard treatments aren’t enough, we have additional options such as the CPNS stimulator.
DOES THE STIMULATOR OR THE DEVICE FOR THE PROCEDURE HAVE A NAME OR A TITLE?
DR EMANI: We call it the CPNS or cardiopulmonary nerve stimulator.
IS IT PART OF A CLINICAL TRIAL?
DR EMANI: It is part of a clinical trial.
DOES THE TRIAL HAVE A NAME?
DR EMANI: The trial does not have a fancy name yet.
SO, IT IS CONSIDERED EXPERIMENTAL. HOW MANY HOSPITALS OR INSTITUTIONS ARE INVOLVED?
DR EMANI: This is actually going to be a worldwide trial. There are several sites in Europe, a couple of sites in South America, and in the United States, the hope is to have ten or more medical centers participating in the trial.
HOW LONG IS THE TRIAL DESIGNED TO RUN?
DR EMANI: We hope to actually get enough patients to get our initial data within a year.
HOW MANY PATIENTS?
DR EMANI: Roughly 20 to 40 patients.
WHEN THE PATIENT WAS IN THE HOSPITAL, HOW LONG WAS HE HOOKED UP? DID YOU SAY IT WAS FOUR DAYS HE WAS ATTACHED TO THE DEVICE?
DR EMANI: I think, Robert, we had for four days.
WILL THAT TIMING CHANGE DEPENDING UPON THE PATIENT AND HOW?
DR EMANI: It does. It’s designed to go up to five days.
WHEN WAS HE DISCHARGED AFTER THAT?
DR EMANI: He was discharged about a day after we took the treatment out.
SO, HE’S FEELING BETTER ALREADY, AND ON THAT FIFTH DAY HE WAS WALKING?
DR EMANI: He was.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Amy Colgan
(614) 425-0424
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here
